Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT03084237
- Lead Sponsor
- Shanghai Henlius Biotech
- Brief Summary
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.
- Detailed Description
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, recurrent or previously untreated metastatic breast cancer. Eligible patients will be assessed centrally for HER2 status and the presence of at least one measurable target lesion before randomization. Patients will undergo a tumor assessment for evaluation of response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) every 6 weeks up to 24 weeks (regardless of the number of cycles actually given); thereafter, assessments will be done every 9 weeks (after Cycles 11, 14, and 17) or earlier in the case of clinical signs of progression.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 652
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Herceptin®+Docetaxel Herceptin® Herceptin®+Docetaxel Herceptin®+Docetaxel docetaxel Herceptin®+Docetaxel HLX02+Docetaxel HLX02 HLX02+Docetaxel HLX02+Docetaxel docetaxel HLX02+Docetaxel
- Primary Outcome Measures
Name Time Method ORR 24 From time of First treatment to week 24 calculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1 by central imaging review (CIR).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions,Complete Response (CR): Disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to\<10 mm, Partial Response (PR): At least a 30% decrease in the sum ofdiameters of target lesions, taking as reference thebaseline sum diameters.Overall Response (OR) = CR + PR.
- Secondary Outcome Measures
Name Time Method DoR Up to 2 years The time from first documentation of CR or PR to the first documentation of progression.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)，At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or Unequivocal progression of existing non-target lesions (Note: the appearance of one or more new lesions is also considered progression).DCR Up to 2 years The percentage of patients who achieve CR, PR, or stable disease (SD) of at least 12 weeks
CBR Up to 2 years The proportion of patients who achieve CR, PR, or durable SD (SD ≥24 weeks)
Median PFS up to 12 Months From time of first treatment to 12 months Median Progression Survival time assessed at 12 months.The probability of being alive without documented progression up to 12 months after randomization.
Overall Survival at 12, 24, and 36 Months From time of first treatment to 36 months the probability of being alive 12, 24, and 36 months after randomization
Trial Locations
- Locations (88)
CI of LRC Lviv Oncological Regional Treatment and Diagnostic Center
🇺🇦Lviv, Ukraine
Odesa Regional Oncologic Dispensary
🇺🇦Odesa, Ukraine
The Medical City
🇵🇭Pasig City, Metro Manila, Philippines
Manila Doctors Hospital
🇵🇭Manila, Metro Manila, Philippines
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Jinan Central Hospital
🇨🇳Jinan, Shangdong, China
General Hospital of the Northern Theater of the Chinese People's Liberation Army
🇨🇳Shenyang, Liaoning, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Beijing Cancer Hospital
🇨🇳Beijing, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
🇨🇳HanGzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Metro Davao Medical and Research Center, Inc.
🇵🇭Davao City, Davao, Philippines
Cardinal Santos Medical Center
🇵🇭San Juan, La Union, Philippines
CI Kryvyi Rih Oncological Dispensary of DRC
🇺🇦Kryvyi Rih, Dnepropetrovsk, Ukraine
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
Nanchong Central Hospital
🇨🇳Nanchong, Sichuan, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Shannxi Provincial Tumor Hospital
🇨🇳Xi'an, Shangxi, China
The 2nd Hospital of Xi'An Jiaotong University
🇨🇳Xi'an, Shanxi, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjing, Tianjing, China
Cebu Doctors University Hospital
🇵🇭Cebu City, Philippines
Chinese PLA General Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The University of Hong Kong-Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of Guangzhou University of TMC
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen University, Cancer Center
🇨🇳Guanzhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University
🇨🇳Zhanjiang, Guangdong, China
Liuzhou General Hospital
🇨🇳Liuzhou, Guangxi, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
Hebei Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The 2nd Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Bayi Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
The Affiliated Drum Tower Hospital of Nanjing University
🇨🇳Nanjing, Jiangsu, China
Wuxi 4th People's Hospital
🇨🇳Wuxi, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Chang chun, Jilin, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Affiliated Hospital of Qinghai University
🇨🇳Xining, Qinghai, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shangdong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
National Institute of Cancer
🇺🇦Kyiv, Ukraine
CNE Kyiv City Clin Oncological Center of Ex Body of Kyiv CC(KCSA)
🇺🇦Kyiv, Ukraine
RCI Sumy Regional Clinical Oncological Dispensary Dept of of Chemotherapy Sumy SU
🇺🇦Sumy, Ukraine
CI Zaporizhzhia Regional Clinical Oncological Dispensary of ZRC
🇺🇦Zaporizhzhia, Ukraine
CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU
🇺🇦Uzhgorod, Outer Carpathian, Ukraine
Transcarpathian Regional Clinical Oncological Dispensary
🇺🇦Uzhgorod, Outer Carpathian, Ukraine
CTPI Chernihiv Regional Oncological Dispensary
🇺🇦Chernihiv, Ukraine
CI of Kherson Reg Council Kherson Regional Oncologic Dispensary
🇺🇦Kherson, Ukraine
Khmelnytskyi Regional Oncological Dispensary
🇺🇦Khmelnytskyi, Ukraine
CI Zaporizhzhia RC Onc Dispensary of ZRC Dept of Breast Pathology SI Zaporizhzhia MA of PGE of MoHU
🇺🇦Zaporizhzhia, Ukraine
CI Carpathian Clinical Oncological Center
🇺🇦Ivano-Frankivs'k, Ivano-Frankivsk, Ukraine
CI Chernivtsi RC Oncological Dispensary
🇺🇦Chernivtsi, Ukraine
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
🇺🇦Kropyvnytskyi, Ukraine
CI Odesa Regional Clinical Hospital
🇺🇦Odesa, Ukraine
Poltava Reg Cl Onc Dispensary of PRC Chemotherapy Dept HSEI of Ukr UMSA
🇺🇦Poltava, Ukraine
Podilskyi Regional Oncological Center
🇺🇦Vinnytsia, Ukraine
CNE"City Clin Hosp#4"of Dnipro City Council Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
🇺🇦Dnipro, Dnipropetrovsk, Ukraine
Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council
🇺🇦Lutsk, Warren, Ukraine
Communal Non-profit Enterprise Regional Center of Oncology
🇺🇦Kharkiv, Ukraine
Kyiv Сity Clinical Oncological Center
🇺🇦Kyiv, Ukraine